Senior Clinical Research Coordinator

Posted 23 Days Ago
Be an Early Applicant
La Jolla, Hermosillo, Sonora, MEX
In-Office
72K-90K Annually
Senior level
Healthtech
The Role
Lead site-level execution of Phase I-III clinical trials from startup through closeout. Manage sponsor/CRO and IRB interactions, participant recruitment and visits, regulatory documentation, EDC data entry, monitoring visits, and mentor junior staff while ensuring GCP/FDA compliance and study timelines.
Summary Generated by Built In

The Senior Clinical Research Coordinator (CRC) is the site-level owner for the onboarding and execution of clinical research studies at Salma Health, from sponsor engagement and study startup through closeout. Reporting to the Clinical Research leadership team and operating with significant autonomy, the Senior CRC is accountable for conducting all research activities in compliance with federal regulations, institutional policies, and Good Clinical Practice (GCP) guidelines. This role actively drives and manages relationships with study sponsors and CROs, and serves as the site’s primary point of contact for sponsors, IRB submissions, and research participants.

Location
The role requires working 5 days a week in person in our La Jolla clinic.

Key Responsibilities

Study Management & Operations

  • Own and drive all operational aspects of assigned clinical trials from startup through closeout, serving as the primary site-level owner

  • Lead site-level review of study protocols, amendments, and informed consent documents

  • Maintain and organize study files, regulatory binders, and essential documents per ICH/GCP guidelines

  • Prepare and submit IRB applications, continuing reviews, amendments, and adverse event reports

  • Lead site feasibility and qualification assessments, and represent the site at sponsor site-selection and initiation visits

  • Own study startup end to end, including essential document collection, regulatory submissions, and site activation, to drive studies to first-patient-in

  • Partner with research leadership on study budgets and Clinical Trial Agreements, and track site-level enrollment, milestones, and deliverables against sponsor timelines

Participant Coordination

  • Recruit, screen, and schedule study participants in accordance with protocol eligibility criteria

  • Conduct study visits, collect data, and perform protocol-specified assessments (e.g., vital signs, EEGs, sample collection) per training and delegation

  • Maintain ongoing communication with participants to support retention and protocol adherence

Data Management

  • Enter and verify data in electronic data capture (EDC) systems (e.g., REDCap, Medidata Rave) with accuracy and timeliness

Regulatory & Compliance

  • Ensure all study activities comply with FDA regulations (21 CFR Parts 50, 54, 56, 312, 812), ICH E6 GCP, and institutional SOPs

  • Host and lead sponsor monitoring visits, internal audits, and regulatory inspections as the site’s primary respondent

Collaboration & Communication

  • Own and actively manage relationships with study sponsors and CROs across feasibility, startup, and study conduct, serving as the site’s primary point of contact alongside the IRB and clinical departments

  • Proactively manage sponsor and CRO expectations on timelines and deliverables, anticipating and escalating risks to enrollment and study milestones

  • Communicate study status, enrollment updates, and issues to the PI and research management team

  • Mentor and provide guidance to junior research staff or volunteers as needed

Required Qualifications

  • Bachelor's degree in a health science, life science, nursing, or related field

  • Minimum 5 years of clinical research with experience running Phase I-III clinical trials or equivalent combination of education and experience

  • Demonstrated experience owning study startup end to end, including site feasibility, regulatory submissions, and site activation

  • Proven experience directly managing sponsor and CRO relationships, including hosting monitoring visits and resolving site-level issues independently

  • Working knowledge of FDA regulations, GCP guidelines, and IRB processes

  • Proficiency with electronic data capture systems and Microsoft Office Suite

  • Strong organizational skills with meticulous attention to detail

  • Excellent written and verbal communication skills

  • Ability to manage multiple priorities in a fast-paced research environment

Preferred Qualifications

  • Familiarity with REDCap, Medidata Rave, or similar EDC platforms

  • Prior clinical research experience in CNS, interventional psychiatry, or neuroscience

  • Experience administering psychiatric or neurological rating scales (e.g., for depression, PTSD, or TBI)

  • Experience as a lead or senior CRC mentoring junior research staff

  • Bilingual or multilingual skills are a plus

Company Mission & Vision
We are the brain health company of the future, integrating care delivery, technology innovation, and research breakthroughs to better understand brain biology and diagnose, treat, and ultimately cure brain disorders across all stages of life.

Who We Are

Salma Health is reimagining brain healthcare by building a comprehensive, end-to-end brain health system that integrates advanced diagnostics, rapid-acting interventions, and continuous care coordination under one roof.

Our multidisciplinary teams of psychiatrists, neurologists, neuropsychiatrists, therapists, and technologists collaborate to deliver personalized, compassionate care. By leveraging real-world data and precision brain health research, we deliver measurable, evidence-based outcomes at scale.

Headquartered in California, Salma Health is expanding access to innovative brain health services across the U.S., beginning with clinics in San Diego, Orange County, the Bay Area, and Los Angeles.

Compensation & Benefits

The compensation for this position includes:

  • Base Salary: $72,000- $90,000 (depending on experience and qualifications)

  • Benefits: Medical, dental, vision, PTO, and additional benefits

We reserve the right to modify benefit offerings at any time, in accordance with applicable laws.

Work Authorization

Sponsorship for employment authorization may be considered on a case-by-case basis depending on the role and candidate qualifications.

Equal Opportunity & Accessibility Statement

We are committed to providing a workplace that is inclusive, respectful, and free from discrimination. We welcome applicants of all backgrounds and make employment decisions without regard to race, color, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, ancestry, citizenship, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, or any other characteristic protected by California or federal law.

In accordance with the California Fair Chance Act, we will consider qualified applicants with arrest and conviction records.

If you require a reasonable accommodation during the application or hiring process, please contact us directly - we’re happy to help.

Skills Required

  • Bachelor's degree in a health science, life science, nursing, or related field
  • Minimum 5 years of clinical research experience running Phase I-III trials (or equivalent)
  • Proven experience owning study startup end to end including site feasibility, regulatory submissions, and site activation
  • Proven experience managing sponsor and CRO relationships, hosting monitoring visits, and resolving site-level issues independently
  • Working knowledge of FDA regulations (21 CFR Parts 50, 54, 56, 312, 812), ICH E6 GCP, and IRB processes
  • Proficiency with electronic data capture (EDC) systems and Microsoft Office Suite
  • Strong organizational skills with meticulous attention to detail
  • Excellent written and verbal communication skills
  • Ability to manage multiple priorities in a fast-paced research environment
  • Work on-site 5 days per week at La Jolla clinic
  • Familiarity with REDCap, Medidata Rave, or similar EDC platforms
  • Prior clinical research experience in CNS, interventional psychiatry, or neuroscience
  • Experience administering psychiatric or neurological rating scales (e.g., depression, PTSD, TBI)
  • Experience as a lead or senior CRC mentoring junior research staff
  • Bilingual or multilingual skills
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The Company
HQ: San Mateo, California
54 Employees

What We Do

Salma Health is a comprehensive brain health clinic combining advanced diagnostics, personalized treatment and continuous care under one roof. Our team specializes in mental health, cognitive health and neurological recovery, offering evidence-based therapies for conditions like depression, anxiety, PTSD and brain injury. From your first evaluation to ongoing care, we guide every step of your journey with clarity, compassion and science-driven support.

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